High Impurity Levels Found in Sagent's Vecuronium Injections
[UPDATE 6/13/13: After the results from additional analyses, Sagent has expanded its recall to include all lots manufactured between July 2011–May 2012. The full list of affected products can be found here: www.sagentpharma.com.]
Sagent Pharmaceuticals announced a voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg (manufactured by MN Pharmaceuticals). This recall is due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval.
The detected impurity elevation has the potential to cause prolonged neuromuscular blockade for critically ill patients with renal failure. The affected lots are 11I30481A, 11I30721A and 11I32581A, which were distributed from January 2012–May 2012.
Vecuronium Bromide for Injection is a non-depolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied in a glass vial.
Sagent's distributors and customers are being notified about this recall and Sagent is arranging for return of all recalled products.
For more information call (866) 625-1618 or visit SagentPharma.com.